A Study of a New Vaccine Against Two Types of Ebola (NCT05079750) | Clinical Trial Compass
CompletedPhase 1
A Study of a New Vaccine Against Two Types of Ebola
United Kingdom26 participantsStarted 2021-11-11
Plain-language summary
An open-label, non-randomised, dose escalation, first-in-human, single centre, phase I clinical trial to determine the safety and immunogenicity of a bivalent ChAdOx1 vectored vaccine against Zaire and Sudan Ebola virus species in healthy adult volunteers.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Healthy adults aged 18 to 55 years.
. Able and willing (in the Investigator's opinion) to comply with all study requirements.
. Willing to allow confirmation of their past medical history either through: provision of a GP medical record summary, allowing investigators to obtain a copy of their medical history from their GP practice or by providing an alternative acceptable means of confirming their past medical history.
. Agreement to refrain from blood donation during the course of the study.
. Provide written informed consent.
. For women of childbearing potential only: Willingness to practice continuous effective contraception for the duration of the trial.
. For women of childbearing potential only: A negative pregnancy test on the day of both screening and vaccination.
Exclusion criteria
. Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment or during the trial follow up period.
. Receipt of a recombinant simian adenoviral vaccine prior to enrolment.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms
Timeframe: 7 days following vaccination
2
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms
Timeframe: 28 days following vaccination
3
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Serious Adverse Events
Timeframe: Duration of the study (6 months)
4
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities
. Planned receipt of another adenoviral vectored vaccine (e.g. Oxford/AstraZeneca or Janssen COVID-19 vaccines) within 90 days after the vaccination with the ChAdOx1 biEBOV.
. Planned or actual receipt of any vaccines administered within 30 days (before or after) enrolment and/or planned receipt of a vaccine ≤30 days after enrolment EXCEPT for protein, RNA (or other non-adenovirus based) COVID-19 vaccinations which may be given within 14 days of the trial vaccine.
. Previous receipt of an Ebolavirus vaccine.
. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate.
. Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) systemically active immunosuppressant medication within the past 6 months.
. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. Including hypersensitivity to the active substance or to any of the excipients of the IMP or Vaxzevria (i.e. the Oxford/AstraZeneca COVID-19 vaccine).